A Prospective Observational Study to evaluate the Gut Microbiome status in Indian advanced Non-Small Cell Lung Cancer Patients receiving Immunotherapy and investigate potential correlations between the gut microbiome composition and treatment outcomes - NI

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1. Those who were willing to participate (via written consent form) in the study.
•2. Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
•3. Age more than 18 years at the time of the study.
•4. PD-L1 tumor expression more than 1 percent
•5. Adequate performance status (e.g., ECOG performance status of 0-2).
•6. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
•7. Prior systemic treatment for metastatic NSCLC will be allowed
•8. Willingness and ability to undergo stool sample collection for gut microbiome analysis.
•9. Patients scheduled to receive immunotherapy as part of their treatment.
•10. Adequate organ function (e.g., liver, kidney, hematological parameters) to tolerate immunotherapy.
•11. Ability to provide informed consent and comply with study requirements.

•1. Previous exposure to immunotherapy or other immune checkpoint inhibitors.
•2. Presence of other active malignancies or history of recent cancer treatment.
•3. History of autoimmune diseases or immunodeficiency disorders.
•4. Current use of antibiotics, probiotics, or other medications known to significantly affect the gut microbiome.
•5. Severe gastrointestinal disorders or conditions that may impact gut microbiota composition (e.g., inflammatory bowel disease).
•6. Inability to provide informed consent or comply with study procedures.
•7. Contraindications to undergoing stool sample collection or microbial analysis (e.g., active gastrointestinal bleeding, recent bowel surgery).

发起方

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)